FDA QSR compliant product development processes are applied, as required, with a strong emphasis on design for manufacture. We also provide significant experience in:

CE, TGA & FDA regulatory environments

Clinical 510K & PMA submissions

ISO13485 compliant manufacturing processes

Post-launch QA/RA processes eg. CAPA, complaints/MDR

As your product is progressing on the development journey, manufacturing processes and commercialization plans are developed in parallel to minimize the time-to-market and maximise the reliability of your final product.